Gastric CancerPhase 2NCT04798781
Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma
A Phase 2 study testing Telatinib and Keytruda in people with Gastric Cancer and Hepatocellular Carcinoma, run by Andrew Hendifar, MD at 3 sites in United States.
Trial summary
This is a phase II, single arm, open-label study of two parallel cohorts (advanced stomach and gastroesophageal junction cancer and hepatocellular carcinoma), evaluating the effects of telatinib in combination with Keytruda on progression-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Hepatocellular Carcinoma
- What is being tested?
- Telatinib and Keytruda
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jul 2021to 20 Oct 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Histologically confirmed gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy. OR: Hepatocellular carcinoma with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance.
- At least 1 measurable metastatic lesion that has not been irradiated. The lesion will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and be documented by radiological evaluation within 28 days prior to registration. For subjects with locally advanced disease: at least one measurable lesion that has not been irradiated, documented by radiological evaluation within 28 days prior to registration.
- Any prior radiation therapy must be completed at least 28 days prior to the first dose of study treatment.
- Eighteen years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2.
- Adequate bone marrow, liver, and renal function
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- Negative urine or serum pregnancy test for women of childbearing potential.
- Women and men of childbearing potential must agree to use adequate contraception prior to registration, for the duration of study participation and until 4 months after the last study drug dosing.
- Able to swallow tablets and agree to take the prescribed tablets twice daily.
Who cannot join
- Clinical or radiographic evidence of current brain metastasis. History of treated brain metastases is allowable.
- Cardiac disease
- Uncontrolled hypertension
- Severe hemorrhage/bleeding event within 28 days prior to the first dose of study treatment
- Major surgery, open biopsy, or significant traumatic injury within 42 days prior to the first dose of study treatment
- Current serious, nonhealing wound, ulcer, or bone fracture within 42 days prior to the first dose of study treatment
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- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment.
- Presence of an uncontrolled infection or infection that required intravenous antibiotics, antifungals, or antivirals within 14 days prior to the first dose of study treatment.
- Known human immunodeficiency virus (HIV) infection. HIV-infected subjects on effective anti-retroviral therapy are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. The safety of telatinib in this subject population has not been studied.
- Known chronic hepatitis B, unless receiving antiviral treatment.
- Known Child-Pugh Score B or C liver cirrhosis.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment or has been diagnosed with an autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Patients that require replacement therapy (e.g., thyroxine [T4], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.
- History of (non-infectious) pneumonitis that required steroids, or current pneumonitis, or has a history of interstitial lung disease.
- Has received a live-virus vaccination within 30 days of planned treatment start.
- Known history of proteinuria > 1gr/24 hours.
- Previous or concurrent cancer that is distinct in primary site or histology from the current stomach or liver cancer. Subjects with cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated are not excluded.
- Anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) or investigational agent within 28 days prior to the first dose of study treatment.
- Known or suspected allergy to any component of telatinib or Keytruda
- Prior or current history of substance abuse, or medical, psychological, or social condition that in the opinion of the investigator may interfere with the subject's participation in the study or evaluation of the study result.
- Women who are pregnant or breastfeeding.
- Prior history of thromboembolic disease, e.g., deep vein thrombosis (DVT), pulmonary emboli (PE), within 6 months prior to the first dose of study treatment that has required continued medical intervention.
- Baseline peripheral neuropathy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
CS Cancer Beverly Hills
Beverly Hills, California, 90211
CS Cancer at The Angeles Clinic and Research Institute
Los Angeles, California, 90025
CS Cancer at the Samuel Oschin Cancer Center
Los Angeles, California, 90048
About this study
Official title: A Phase II Study Evaluating Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma
This is a phase II, single arm, open-label study of two parallel cohorts (advanced stomach and gastroesophageal junction cancer and hepatocellular carcinoma), evaluating the effects of telatinib in combination with Keytruda on progression-free survival.
- Conditions
- Gastric Cancer, Hepatocellular Carcinoma
- Being tested
- Telatinib, Keytruda
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelatinibDrug
900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
KeytrudaDrug
Also called pembrolizumab
200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
| Study group | Role | What they receive |
|---|---|---|
| telatinib + Keytruda | Experimental | Not described Receives: Drug: Telatinib; Drug: Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Duration of time from start of treatment until progression or death, whichever comes first
Measured: through study completion, approximately 2.5 years
Secondary outcomes (4)
Overall Response Rate
The percentage of patients who have a partial or complete response to treatment
Measured: from the start of treatment until the end of treatment, approximately 12 months
Disease Control Rate
The percentage of patients who have stable disease, partial response, or complete response to treatment
Measured: from the start of treatment until the end of treatment, approximately 12 months
Overall Survival
The length of time from the start of treatment that patients are still alive
Measured: from the start of treatment until time-of-event
Number and Severity of Adverse Events
Incidence and severity of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5
Measured: from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first), approximately 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start28 Jul 2021
- Primary completion14 Feb 2024
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Hendifar, MD
- Sponsor type
- University, hospital or other
- Collaborators
- EOC Pharma
- Responsible party
- Sponsor-investigator, Andrew Hendifar, MD, Cedars-Sinai Medical Center
- Investigators
- Andrew Hendifar, MD, MPH, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798781
- Sponsor's protocol ID
- IIT2020-11-Hendifar-TELAT
- Status last verified
- Nov 2025
- First submitted
- 24 Feb 2021
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04798781
- Acronym / sponsor ID
- IIT2020-11-Hendifar-TELAT
- Conditions
- Gastric Cancer, Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Andrew Hendifar, MDUniversity, hospital or other
- Collaborators
- EOC Pharma
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, single arm, open-label study of two parallel cohorts (advanced stomach and gastroesophageal junction cancer and hepatocellular carcinoma), evaluating the effects of telatinib in combination with Keytruda on progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| telatinib + Keytruda | Experimental | Drug: Telatinib, Drug: Keytruda |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis: Histologically confirmed gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy. OR: Hepatocellular carcinoma with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance.
- At least 1 measurable metastatic lesion that has not been irradiated. The lesion will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and be documented by radiological evaluation within 28 days prior to registration. For subjects with locally advanced disease: at least one measurable lesion that has not been irradiated, documented by radiological evaluation within 28 days prior to registration.
- Any prior radiation therapy must be completed at least 28 days prior to the first dose of study treatment.
- Eighteen years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2.
Key exclusion criteria (22 listed)
- Clinical or radiographic evidence of current brain metastasis. History of treated brain metastases is allowable.
- Cardiac disease
- Uncontrolled hypertension
- Severe hemorrhage/bleeding event within 28 days prior to the first dose of study treatment
- Major surgery, open biopsy, or significant traumatic injury within 42 days prior to the first dose of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telatinib900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent | Drug | telatinib + Keytruda |
| KeytrudaAlso: pembrolizumab200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent | Drug | telatinib + Keytruda |
Primary outcome
Progression-free Survival
Time frame: through study completion, approximately 2.5 years
Duration of time from start of treatment until progression or death, whichever comes first
4 secondary outcomes
Overall Response Rate
Time frame: from the start of treatment until the end of treatment, approximately 12 months
Disease Control Rate
Time frame: from the start of treatment until the end of treatment, approximately 12 months
Overall Survival
Time frame: from the start of treatment until time-of-event
Number and Severity of Adverse Events
Time frame: from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first), approximately 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Hendifar, MD, MPH principal investigator
Cedars-Sinai Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telatinib and Keytruda in people with Gastric Cancer and Hepatocellular Carcinoma, run by Andrew Hendifar, MD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: through study completion, approximately 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.